Submission Outsourcing

Full or Partial Support During the eCTD Lifecycle

Impending eCTD submission mandates in multiple regions, coupled with the efficiencies and benefits of adopting an e-submission program, are speeding the rate of eCTD adoption. Full or partial submission outsourcing is now a popular option for pharmaceutical and biotechnology companies implementing eCTD – although there are a number of factors to consider prior to finalizing a game plan.

What are the Advantages of eCTD Submission Outsourcing?

The fastest and most efficient way for small to mid-size pharmaceutical companies to transition from paper to electronic submissions is outsourcing. The costs and time associated with bringing an eCTD operation in house (which include acquiring software, developing processes, training staff, and publishing) are considerable. A company with little hands-on experience publishing in eCTD format also faces a greater risk of technical errors. While outsourcing constitutes a short-term expense, adding personnel, hardware and instituting process changes necessary to complete an eCTD submission requires capital investment and recurring costs that must be realistically calculated prior to opting for an in-house approach.

Is Outsourcing a Viable Short-Term Solution?

Adopting eCTD publishing should be viewed not only as an upgrade to a modern submission methodology, but a transitional period for your entire regulatory team. If your organization intends to ultimately bring submission publishing in house, treating outsourcing as a bridge to electronic submissions is an effective solution.

Beginning new drug applications and biologic license applications in the eCTD format maximizes the benefits inherent in electronic submissions throughout the development phases of the project. Nonetheless, to convert existing paper submissions to electronic ones, a transition plan must be determined. Your organization can focus on implementing process changes that impact submission contributors in the short term, and leave the larger task of implementing eCTD software and building a department of regulatory operations staff to be addressed as part of long-term business goals.

A Hybrid Approach to Manage Workload Fluctuations

Many of our clients are working on more than one submission at a time. To compensate for this volume, additional resources are pulled from other departments or brought into the organization on a temporary/permanent basis. Synchrogenix provides a hybrid solution to manage workload peaks and valleys. As an experienced publishing partner, Synchrogenix can step in at any point in the submission cycle to augment in-house resources. This combination of outsourcing and generating submissions internally is cost effective and gives organizations the flexibility needed to succeed in a deadline-driven industry.

Does your Vendor Offer a Cloud Environment that Promotes Collaboration?

As working from home becomes increasingly more common in the 21st century, members of your team must find new ways to work together to generate a successful eCTD output. One of your foremost considerations when selecting an outsourcing partner is that partner’s ability to deliver access to a centralized repository where documents can be shared and modified remotely.

Beyond eCTD Publishing

While finding the right eCTD Publishing vendor provides tremendous value to an organization short on internal resources, pairing with a vendor that can offer extensive Regulatory Strategy, Regulatory Affairs, Regulatory and Medical Writing experience brings numerous synergies. The understanding that a vendor can be well versed in a program and quickly provide services as needed across a multitude of potential needs can provide higher quality submissions at expedited speeds. Accommodating to the numerous curveballs that will inevitably be thrown your way.

Other Considerations:

Does your partner have experience preparing submissions for multiple regions?

Does your provider use offshore resources?

Does your provider have adequate and backup resources for your project?

How will your provider demonstrate status and progress?

How will the work be divided?

What quality control standards will your partner use?

How will your partner validate the eCTD? What checks will be made?

How will you review and QC the submission after your partner has prepared it?